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Low Back PainPhase 2/3HiLoBaSNCT01900925

Does Prescriptive Treatment of the Hips Improve Outcomes in Patients With Low Back Pain? A Randomized Controlled Trial

A Phase 2/3 study testing Prescriptive Hip Exercises and Manual Therapy techniques and Pragmatic low back pain treatment in people with Low Back Pain, run by Regis University at 1 site in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

There will be two groups of patients with low back pain (by randomization). Both groups will receive a pragmatic treatment approach by physical therapists for low back pain. One group will also receive a prescriptive treatment approach for both hips. Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Low Back Pain
What is being tested?
Prescriptive Hip Exercises and Manual Therapy techniques and Pragmatic low back pain treatment
Type of treatment
Surgery or procedure
Could I receive a placebo?
No, everyone receives an active treatment
How many people
90 participants
Where
1 siteUnited States
Study dates
Sep 2013to Mar 2016
Phase
Phase 2/3
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 18 years of age or older
  • Mechanically producible LBP.
  • Minimum Modified Oswestry Disability Index score of 20%
  • Minimum baseline pain score of >2.0/10 on the numeric analog scale for pain

Who cannot join

  • Presence of any red flags
  • Signs consistent with nerve root compression
  • Prior surgery to the lumbar spine
  • Current pregnancy

Trial locations and contacts

1 site in 1 country.

United States1 site

  • Regis University

    Denver, Colorado, 80221

Other trials in United States

About this study

There will be two groups of patients with low back pain (by randomization). Both groups will receive a pragmatic treatment approach by physical therapists for low back pain. One group will also receive a prescriptive treatment approach for both hips. The investigators feel that the additional of a standardized exercise program and stretching for the hips will improve outcomes in patients with mechanical low back pain.

Read the detailed description

It has been suggested that treatment of the hips should improve outcomes in patients with mechanical low back pain. This has yet to be studied in a randomized controlled fashion or in a conservative venue. For this study, there will be two groups of patients with low back pain (by randomization). For inclusion into the randomized clinical trial, patients will need to be 18 years of age or older with mechanically producible LBP. They will require a minimum Modified Oswestry Disability Index score of 20% and a baseline pain score of >2.0/10 on the numeric analog scale for pain, and a within session change (improvement during the visit) in pain and/or range of motion during the assessment phase of the clinical examination. This finding has been advocated as an effective mechanism to determine if a patient is a candidate for manual therapy. Exclusion criteria will include the presence of any red flags (i.e., tumor, metabolic diseases, rheumatoid arthritis, osteoporosis, prolonged history of steroid use, etc.), or signs consistent with nerve root compression (reproduction of low back or leg pain with straight leg raise at less than 45°, muscle weakness involving a major muscle group of the lower extremity, diminished lower extremity muscle stretch reflex, or diminished or absent sensation to pinprick in any lower extremity dermatome). Other exclusion criteria include prior surgery to the lumbar spine and current pregnancy. Both groups will receive a pragmatic treatment approach by physical therapists for low back pain. One group will also receive a prescriptive treatment approach for both hips. The investigators will track the outcomes of disability (Oswestry), Pain (Numeric pain rating scale), and recovery at baseline, 2 weeks, and discharge. Our aims are to determine if differences in groups exist, with our primary outcome measure of ODI. The investigators feel that the additional of a standardized exercise program and stretching for the hips will improve outcomes in patients with mechanical low back pain.

Conditions
Low Back Pain
Being tested
Prescriptive Hip Exercises and Manual Therapy techniques, Pragmatic low back pain treatment
Keywords
Low back pain, non-specific low back pain
Medical subject headings
Low Back Pain

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Prescriptive Hip Exercises and Manual Therapy techniquesProcedure or surgery

    1. Clam Abduction exercises in sidelying, 2) Hip extension in quadruped, 3) a unilateral bridge,and; 1) anterior to posterior mobilization of the hip with distraction, 2) long axis distraction of the hip and 3) posterior-anterior mobilization of the hip in prone

  • Pragmatic low back pain treatmentProcedure or surgery

    Also called Low back pain treatment

    1. advise to stay active,
    2. discourage bed rest,
    3. appropriate medication use,
    4. reassurance.
    5. Short term use of manipulation/medication,
    6. supervised exercise,
    7. cognitive behavioral therapy,
    8. multidisciplinary treatment,
    9. termination of use of modalities.
Study groups in NCT01900925
Study groupRoleWhat they receive
Low back treatment only (pragmatic)Active comparator1. advise to stay active, 2. discourage bed rest, 3. appropriate medication use, 4. reassurance. 5. Short term use of manipulation/medication, 6. supervised exercise, 7. cognitive behavioral therapy, 8. multidisciplinary treatment, 9. termination of use of modalities.
Receives: Procedure: Pragmatic low back pain treatment
LBP treatment and Hip treatmentExperimentalGroup two will receive the same pragmatically applied, guideline-oriented treatment that is recommended from group 1. In addition, group 2 will receive prescriptive hip exercises that include 1) Clam Abduction exercises in sidelying, 2) Hip extension in quadruped, 3) a unilateral bridge, and the manual therapy treatment techniques of; 1) anterior to posterior mobilization of the hip with distraction, 2) long axis distraction of the hip and 3) posterior-anterior mobilization of the hip in prone.26 (See Appendix A for photos of the techniques and descriptions)
Receives: Procedure: Prescriptive Hip Exercises and Manual Therapy techniques; Procedure: Pragmatic low back pain treatment

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Change in Modified Oswestry Disability Index

    The Modified Oswestry Disability Index (ODI) will be used to measure disability, will serve as the primary outcome measure for the study, and consists of 10 questions each scored from 0 to 5, with higher scores indicating greater disability. A 50% reduction in the ODI or greater from baseline has been considered a clinically important outcome.

    Measured: Baseline, 2 weeks, End of Intervention (Discharge)

Secondary outcomes (4)

  1. Change in Numeric Pain Rating Scale

    An 11-point NPRS will be used to measure pain intensity. The scale is anchored on the left with the phrase "No Pain" and on the right with the phrase "Worst Possible Pain". NPRSs have been shown to be reliable and valid.32 Patients rate their current level of pain and their worst and least amount of pain experienced during the last 24 hours.

    Measured: Baseline, 2 weeks, End of Intervention (Discharge)

  2. Recovery

    A recent study has summarized the assortment of definitions associated with recovery.30 Recovery definitions associated with pain have ranged from 1) an absence of pain, to a maximal level of pain (e.g., 2/10 on an 11 point scale). Recovery definitions affiliated with function have included; 1) no functional dysfunction to 2) maximal level of functional loss (e.g., 20%/100% on a disability index). None have defined recovery in terms of a patient's perspective of recovery such as the patient acceptable symptom state (PASS) score. The PASS is the state beyond which patients consider their state as acceptable and are unlikely to seek further treatment.31 Thus, therapeutic success can be defined at the individual level (i.e., for each patient) as an improvement greater than minimum clinically acceptable score, or as achieving a state acceptable at the end of the care.31 For our study, recovery is defined as a "yes" (patients consider their state as acceptable) on the PASS at discharge.

    Measured: End of Intervention (Discharge)

  3. Change in Global Rating of Change Score

    The fifteen-point global rating scale described by Jaeschke et al.,33 will be used. The scale ranges from -7 (a very great deal worse) to zero (about the same) to +7 (a very great deal better). The global rating scale will be administered at 4 visits, 1 month, and 6 months.

    Measured: 2 weeks and End of Intervention (Discharge)

  4. Change in Patient Satisfaction

    An 11-point patient satisfaction measure will be used to capture the patient's overall satisfaction with their intervention. The scale is anchored on the left with the phrase "Completely Dissatisfied" and on the right with the phrase "Completely Satisfied".

    Measured: 2 weeks and End of Intervention (Discharge)

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted17 Jul 2013 (estimated)
  2. Study startSep 2013
  3. Primary completionDec 2015
  4. Study completionMar 2016

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 2/3
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
90 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT01900925
Sponsor's protocol ID
CC1937
Acronym
HiLoBaS
Status last verified
Apr 2016
First submitted
7 Jul 2013
Last updated
2 May 2016
Results posted
No
Data monitoring committee
No

Questions about this trial

What is this clinical trial studying?

A Phase 2/3 study testing Prescriptive Hip Exercises and Manual Therapy techniques and Pragmatic low back pain treatment in people with Low Back Pain, run by Regis University at 1 site in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 4 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 2 May 2016. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this combined phase mean?

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Change in Modified Oswestry Disability Index (time frame: Baseline, 2 weeks, End of Intervention (Discharge)). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT01900925.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 2 May 2016.

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